The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Proforma Hf 4.5 Cannula, Model 050906, 050907.
| Device ID | K050777 |
| 510k Number | K050777 |
| Device Name: | PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CONMED CORP. 129 CONCORD ROAD BUILDING 3 Billerica, MA 01821 |
| Contact | Michael A Patz |
| Correspondent | Michael A Patz CONMED CORP. 129 CONCORD ROAD BUILDING 3 Billerica, MA 01821 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-28 |
| Decision Date | 2005-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50653405051419 | K050777 | 000 |
| 10653405051428 | K050777 | 000 |